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BACKGROUND: We compared Fakhravac and BBIBP-Corv2 vaccines in a phase III trial. METHOD: We conducted a multicenter, parallel-group, active-control, non-inferiority clinical trial with pragmatic considerations assessing the safety and efficacy of Fakhravac and BBIBP-Corv2 vaccines. We started with two randomized double-blind arms and added two non-randomized open-label arms (based on participant preference) because of slow recruitment. The adult population received 0.5 ml (10 µg per dose) intramuscular injections of Fakhravac or BBIBP-Corv-2 vaccines 21 days apart. The primary outcome was the occurrence of PCR-positive symptomatic Covid-19 disease 14 days or more after the second injection. A 10% non-inferiority margin to the reported 72.8% efficacy of BBIBP-Corv2 was assumed. Cox proportional hazard modeling was used to estimate hazard ratios and their 95% confidence intervals. RESULT: We enrolled 24,056 adults in four groups (randomized-Fakhravac: 824, randomized-BBIBP-Corv2: 832; Non-randomized-Fakhravac: 19,429, Non-randomized-BBIBP-Corv2: 2971). All observed local and systemic adverse reactions were generally self-limited and resolved completely. We observed similar Serious Adverse Event (SAE) rates in the BBIBP-Corv2 (2.57, 95% CI 1.33-4.49) and Fakhravac (2.25, 95% CI 1.72-2.89) groups; none of which were related to the vaccines received. We recorded 9815 Medically Attendant Adverse Events (MAAE), 736 of which were categorized as somehow related. The rate of related MAAE in the Fakhravac was similar to the BBIBP-Corv2 groups (0.31 and 0.26 per 1000 person-day) in the randomized and considerably higher (0.24 and 0.07 per 1000 person-day) in the non-randomized arms. We observed 129 (35% of the 365 required by target sample size) events of PCR + symptomatic Covid-19 during four months of active follow-up in the randomized arm, demonstrating that those receiving the Fakhravac vaccine were significantly less likely (HR = 0.69; 95% CI 0.49-0.98) to be diagnosed with PCR + symptomatic Covid-19 compared with those receiving BBIBP-Corv2 vaccine. After adjusting for type I error using the O'Brien Fleming method, the Fakhravac vaccine was non-inferior to the BBIBP-Corv2 (assuming a 10% non-inferiority margin to the reported 72.8% BBIBP-Corv2 vaccine efficacy; HR < 1.35) (One-way test: HR = 0.66; 99.8% CI 0.38-1.15). In the non-randomized arm, the results were inconclusive (HR = 1.23; 95% CI 0.96-1.61). We observed 5 cases of hospitalized Covid-19 in the randomized arm, none of which occurred in the Fakhravac vaccine group. Those receiving the Fakhravac vaccine were four times less likely to go to the hospital because of a Covid-19 diagnosis (HR = 0.24; 95% CI 0.10-0.60). The vaccine efficacy of the Fakhravac vaccine is estimated to be 81.5% (95% CI 81-82.4%). CONCLUSION: Fakhravac inactivated SARS-CoV-2 vaccine has comparable safety and efficacy to the BBIBP-Corv2 vaccine. Trial registration This study was registered with the Iranian Registry of Clinical Trials ( www.irct.ir : IRCT20210206050259N3).
Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , Humans , SARS-CoV-2 , COVID-19/prevention & control , COVID-19 Testing , Iran , Double-Blind MethodABSTRACT
BACKGROUND: The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial. METHODS: We did a phase II, single-centered, randomized, double-blind, placebo-controlled clinical trial of the FAKHRAVAC inactivated SARS-CoV-2 vaccine on adults aged 18 to 70. The two parallel groups received two intramuscular injections of either a 10-µg vaccine or a placebo at 2-week intervals. The participants' immunogenicity responses and the occurrence of solicited and unsolicited adverse events were compared over the study period of up to 6 months. Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels. RESULTS: Five hundred eligible participants were randomly (1:1) assigned to vaccine or placebo groups. The median age of the participants was 36 years, and 75% were male. The most frequent local adverse reaction was tenderness (21.29% after the first dose and 8.52% after the second dose), and the most frequent systemic adverse reaction was headache (11.24% after the first dose and 8.94% after the second dose). Neutralizing antibody titers two and four weeks after the second injection in the vaccine group showed about 3 and 6 times increase compared to the placebo group (GMR = 2.69, 95% CI 2.32-3.12, N:309) and (GMR = 5.51, 95% CI 3.94-8.35, N:285). A four-fold increase in the neutralizing antibody titer was seen in 69.6% and 73.4% of the participants in the vaccine group two and four weeks after the second dose, respectively. Specific ELIZA antibody response against a combination of S1 and RBD antigens 4 weeks after the second injection increased more than three times in the vaccine compared to the placebo group (GMR = 3.34, 95% CI 2.5-4.47, N:142). CONCLUSIONS: FAKHRAVAC® is safe and induces a significant humoral immune response to the SARS-CoV-2 virus at 10-µg antigen dose in adults aged 18-70. A phase III trial is needed to assess the clinical efficacy. TRIAL REGISTRATION: Trial Registry Number: Ref., IRCT20210206050259N2 ( http://irct.ir ; registered on 08/06/2021).
Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , Humans , Male , Female , SARS-CoV-2 , Antibodies, Neutralizing , Antibody Formation , Double-Blind Method , Immunogenicity, Vaccine , Antibodies, ViralABSTRACT
Vestibular neuritis was first reported in 1952 by Dix and Hallpike, and 30% of patients reporting a flu-like symptom before acquiring the disorder. The most common causes are viral infections, often resulting from systemic viral infections or bacterial labyrinthitis. Here we presented a rare case of acute vestibular neuritis after the adenoviral vector-based COVID-19 vaccination. A 51-year-old male pilot awoke early in the morning with severe vertigo, nausea, and vomiting after receiving the first dose of the ChAdOx1 nCoV-19 vaccine 11 days ago. Nasopharyngeal SARS-CoV-2 RT-PCR test and chest CT scan were inconclusive for COVID-19 pneumonia. Significant findings were a severe spontaneous and constant true-whirling vertigo which worsened with head movement, horizontal-torsional spontaneous nystagmus, abnormal caloric test, positive bedside head impulse tests, and inability to tolerate head-thrust test. PTA, MRI of the brain and internal auditory canal, and cerebral CT arteriography were normal. According to the clinical, imaging, and laboratory findings, he was admitted to the neurology ward and received treatment for vestibular neuritis. His vertigo increased gradually over 6-8 h, peaking on the first day, and gradually subsided over 7 days. Ten days later, the symptoms became tolerable; the patient was discharged with advice for home-based vestibular rehabilitation exercises. Despite the proper treatment and rehabilitation, signs of dynamic vestibular imbalances persisted after 1 year. Based on the Federal Aviation Administration (FAA) regulations, the Air Medical Council (AMC) suspended him from flight duties until receiving full recovery. Several cases of vestibular neuritis have been reported in the COVID-19 patients and after the COVID-19 vaccination. This is the first case report of acute vestibular neuritis after the ChAdOx1 nCoV-19 vaccination in a healthy pilot without past medical history. However, the authors believe that this is a primary clinical suspicion that must be considered and confirmed after complete investigations.
Subject(s)
COVID-19 Vaccines , COVID-19 , Vestibular Neuronitis , Humans , Male , Middle Aged , ChAdOx1 nCoV-19 , COVID-19/complications , COVID-19 Vaccines/adverse effects , SARS-CoV-2 , Vertigo/etiology , Vestibular Neuronitis/diagnosis , Vestibular Neuronitis/complications , Vestibular Neuronitis/therapy , Virus Diseases/complicationsABSTRACT
OBJECTIVES: Evaluation of the incidence of infectious diseases after natural disasters can help develop healthcare policies. This study provides a global review of the most prevalent infectious diseases observed after earthquakes. STUDY DESIGN: A systematic review and meta-analysis were performed. METHODS: A systematic review was performed on electronic databases, including PubMed, Scopus and Web of Science, up to March 2020 (with no time limitations). Studies addressing earthquakes and infectious diseases were collected based on specified inclusion and exclusion criteria. Subsequently, the quality of the studies was assessed by the Newcastle-Ottawa scale (NOS). Data analyses were carried out on six subgroups under five different disease categories using comprehensive meta-analysis software. RESULTS: In total, 24 studies qualified for the systematic review and 18 were included in the meta-analysis. The incidences of gastrointestinal infections, dermal infections, respiratory infections, central nervous system infections and other infectious diseases were as follows: odds ratio (OR) 163.4 (95% confidence interval [CI]: 31.0-858.1), OR 84.5 (95% CI: 27.1-262.8), OR 9.9 (95% CI: 3.5-27.7), OR 0.5 (95% CI: 0.2-1.1) and OR 4.4 (95% CI: 1.9-9.9) cases per 100,000 people, respectively. The association between the incidences of infectious diseases before and after earthquakes was significant, namely, 1.561 (95% CI: 1.244-1.957) with a P-value <0.001. CONCLUSIONS: The results show an increase in the prevalence of infectious diseases after earthquakes. Governments should take essential measures to be better prepared for such unpredictable catastrophes.
Subject(s)
Communicable Diseases , Earthquakes , Respiratory Tract Infections , Humans , Incidence , PrevalenceABSTRACT
Resistance-Nodulation-Division (RND) efflux pumps are responsible for multidrug resistance in Pseudomonas aeruginosa. The present study aimed to evaluate the overexpression of RND efflux pumps and its role in the antibiotic resistance of P. aeruginosa clinical isolates. A number of 122 isolates were obtained from three military hospitals in Tehran, Iran. In order to determine the antibiotic resistance, the isolates were identified and assessed by the disk diffusion and agar dilution methods. This study investigated the gene expression of four multi-drug efflux pump systems (MexAB-OprM, MexCD-OprJ, MexEF-OprN and MexXY (-OprA)) and its correlation with antibiotic resistance. The isolates indicated that the highest resistance rate was against ticarcillin (80%), followed by ciprofloxacin (74%) and meropenem (71%). Most of them expressed mexB (69%), mexC (28.7%), mexE (43.4%), and mexY (74.6%), suggesting that mexB and mexY were highly expressed in the studied strains. The overexpression of mexB and mexY was significantly more prevalent in the ICU wards (p = 0.033). Furthermore, there was a significant correlation between the expression of RND-type efflux pumps and the resistance to most anti-pseudomonal antibiotics.
Subject(s)
Bacterial Outer Membrane Proteins , Pseudomonas aeruginosa , Anti-Bacterial Agents/pharmacology , Bacterial Outer Membrane Proteins/genetics , Bacterial Outer Membrane Proteins/metabolism , Drug Resistance, Microbial , Iran , Membrane Transport Proteins/genetics , Microbial Sensitivity Tests , Pseudomonas aeruginosa/genetics , Pseudomonas aeruginosa/metabolismABSTRACT
BACKGROUND: Sniffer dogs are able to detect certain chemical particles and are suggest to be capable of helping diagnose some medical conditions and complications, such as colorectal cancer, melanoma, bladder cancer, and even critical states such as hypoglycemia in diabetic patients. With the global spread of COVID-19 throughout the world and the need to have a real-time screening of the population, especially in crowded places, this study aimed to investigate the applicability of sniffer dogs to carry out such a task. METHODS: Firstly, three male and female dogs from German shepherd (Saray), German black (Kuzhi) and Labrador (Marco) breeds had been intensively trained throughout the classical conditioning method for 7 weeks. They were introduced to human specimens obtained from the throat and pharyngeal secretions of participants who were already reported positive or negative for SARS-COV-2 infection be RT-PCR. Each dog underwent the conditioning process for almost 1000 times. In the meantime another similar condition process was conducted on clothes and masks of COVID-19 patient using another three male and female dogs from Labrador (Lexi), Border gypsy (Sami), and Golden retriever (Zhico) breeds. In verification test for the first three dogs, 80 pharyngeal secretion samples consisting of 26 positive and 54 negative samples from different medical centers who underwent RT-PCR test were in a single-blind method. In the second verification test for the other three dogs, masks and clothes of 50 RT-PCR positive and 70 RT-PCR negative cases from different medical center were used. RESULTS: In verification test using pharyngeal secretion, the sniffer dogs' detection capability was associated with a 65% of sensitivity and 89% of specificity and they amanged to identify 17 out of the 26 positive and 48 out of the 54 true negative samples. In the next verification test using patients' face masks and clothes, 43 out of the 50 positive samples were correctly identified by the dogs. Moreover, out of the 70 negative samples, 65 samples were correctly found to be negative. The sensitivity of this test was as high as 86% and its specificity was 92.9%. In addition, the positive and negative predictive values were 89.6 and 90.3%, respectively. CONCLUSION: Dogs are capable of being trained to identify COVID-19 cases by sniffing their odour, so they can be used as a reliable tool in limited screening.
Subject(s)
COVID-19 Testing/methods , COVID-19 , Mass Screening/methods , SARS-CoV-2 , Working Dogs , Animals , COVID-19/diagnosis , COVID-19/epidemiology , Dogs , Female , Humans , Iran/epidemiology , Male , Predictive Value of Tests , Proof of Concept Study , SARS-CoV-2/isolation & purification , SARS-CoV-2/physiology , Sensitivity and Specificity , Single-Blind MethodABSTRACT
The present study was done to evaluate the prevalence of intestinal parasitic infections (IPIs) in patients with COVID-19 in health care centers (Imam Reza and Golestan hospitals), Tehran, capital of Iran. By designing a matched case-control study, 200 fecal samples were collected for each of the COVID-19 patients and healthy individuals. Nasopharyngeal/oropharyngeal swab samples were collected from all participants for the diagnosis of COVID-19. RNA extraction was performed, and then real time reverse-transcription polymerase chain reaction (rRT-PCR) assay was applied to detect viral RNA. Considering the lung complications, 25%> lung complications was detected in 49 patients, 25-49% in 42 patients, and 50%≤ in 109 patients. Fecal samples were examined using different parasitological techniques. After nested-PCR, sequencing was applied to identify Cryptosporidium spp. and microsporidia spp. A relatively lower prevalence of IPIs was detected among control group (7.5%), than in COVID-19 patients (13%), though not significant (P=0.13). The most prevalent parasite among patients was Blastocystis sp. (6%). Also, 13.76% of IPIs were detected in inpatients with more than 50% lung complication. As well, a remarkably significant difference in IPIs was observed among diarrheic COVID-19 patients, in comparison with nondiarrheic patients (P < 0.00001). Moreover, the isolated sequences in the present study belonged to C. parvum subtype IIa and Enterocytozoon bieneusi genotypes D and Peru 8. In conclusion, more epidemiological and clinical research studies are needed to better understand the status and interaction of IPI in COVID-19 in Iran and other countries.
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Background: Recent theories on the possible interactions between the intestinal parasites and COVID-19 have stated that these co-infections may cause immune imbalance and further complications in the affected patients. Until now, there is no data about Blastocystis subtypes as an intestinal parasite in COVID-19 patients. Therefore, the present work was done to evaluate the molecular prevalence of Blastocystis spp. and related risk factors in Iranian patients with COVID-19. Method: Stool samples were gathered from 200 COVID-19 patients and 200 control, being matched regarding age, gender and residence. Then, stool samples were surveyed by parasitological methods, including direct slide smear and formalin-ether concentration. In the following, PCR and sequencing were used to detect Blastocystis spp. and their subtypes. Results: The frequency of Blastocystis spp. in patients with COVID-19 (7.5%; 15/200 by molecular method vs. 6%; 12/200 by microscopy method) was slightly higher than in individuals without COVID-19 (4.5%; 9/200 by molecular method vs. 4%; 8/200 by microscopy method), this difference was not statistically significant (P value = 0.57 for molecular method vs. P value = 0.81 for microscopy method). Regarding associated factors for Blastocystis spp., we found significant differences regarding the residence (rural), loose and watery stool with diarrhea, and duration of treatment (6 weeks <) in the COVID-19 group. Blastocystis ST3 was the most common subtype in the patients with COVID-19 and control group. Conclusions: Based on this results, health education, improved sanitation and good personal hygiene are highly recommended to prevent Blastocystis in COVID-19 patients.
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BACKGROUND: SARS-CoV-2 may affect vital organs. The present study investigated the histopathology of pulmonary and cardiac tissues with clinical correlation in deceased patients with COVID-19. METHODS: We obtained pulmonary and cardiac tissues from 30 deceased patients with COVID-19 in Tehran, Iran, from January to May 2021. Sampling was performed through a percutaneous needle biopsy. After slide preparation, two expert pathologists studied them. We assessed the correlation between clinical and pathological data by Fisher's exact test. RESULTS: The mean age of the patients was 73.8±13.4 years, and the male-to-female ratio was 23/7. The most common underlying disease was hypertension (HTN) in 25 patients (83%). Fifty-five tissue samples were achieved, including 28 pulmonary and 27 cardiac samples. Our results showed that all patients (100%) developed diffuse alveolar damage (DAD), and 26 (93%) developed hyaline membrane formation. The most common phase of DAD was the exudative-proliferative phase in 16 (57.1%). Three cardiac samples (11%) revealed myocarditis, and seven (26%) showed cardiomyocyte hypertrophy. In univariate analysis using Fischer's exact test, myocarditis had significant relationships with C-reactive protein (CRP) levels higher than 80 mg/dL (P=0.008) and elevated cardiac troponin levels higher than two-fold (P=0.01). CONCLUSION: COVID-19 can affect the major vital organs. However, only myocarditis had a significant relationship with the circulating levels of inflammatory factors.
Subject(s)
COVID-19 , Myocarditis , Humans , Male , Female , Middle Aged , Aged , Aged, 80 and over , COVID-19/pathology , SARS-CoV-2 , Myocarditis/pathology , Iran/epidemiology , Lung/pathologyABSTRACT
Aim: The present double-blinded placebo-controlled randomized clinical trial evaluated prophylactic use of acetylcysteine for the prevention of liver injury in patients with severe COVID-19 pneumonia under treatment with remdesivir. Background: Liver injury is reportedly common in patients with severe COVID-19 pneumonia and can occur not only as a result of disease progression, but as an iatrogenic reaction to remdesivir. Methods: A total of 83 adult patients with severe COVID-19 pneumonia were randomly assigned in parallel groups to receive either acetylcysteine or placebo. All the patients received standard care according to institutional protocols, including remdesivir for a total of five days. One gram acetylcysteine was administered intravenously every 12 hours for 42 patients, and 41 patients received the same volume of 0.9% sodium chloride as placebo (Trial Registration: www.irct.ir identifier, IRCT20210726051995N1). Results: After 5 days, median aspartate transaminase (AST) and alanine transaminase (ALT) levels were significantly lower in the acetylcysteine than in the placebo group. Of those who received the placebo, 30 (73.2%), 4 (9.7%), and 3 (7.3%) patients had serum AST levels elevated between 1-2.5, 2.5-5, and over 5 times the upper limit of normal (ULN), respectively; while in the acetylcysteine group, 33 (78.6%) and 0 patients had AST levels between 1-2.5 and over 2.5 times ULN, respectively (p-value=0.037). In the acetylcysteine group, 23 (54.8%), 1 (2.4%), and 1 (2.4%) patient had serum ALT levels elevated between 1-2.5, 2.5-5, and over 5 times ULN, respectively; in the placebo group, however, 24 (58.5%), 7 (17.1%), and 1 (2.4%) patient had serum ALT levels between 1-2.5, 2.5-5, and over 5 times ULN, respectively (p-value=0.073). Conclusion: Intravenous administration of acetylcysteine significantly prevents liver transaminases elevation and liver injury in seriously ill COVID-19 patients treated with remdesivir.
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Background: Severe acute respiratory syndrome (SARS) coronavirus-2 may infect red blood cells (RBCs) and impact oxygenation. We aimed to evaluate the efficacy of RBC exchange as an adjunctive treatment for hypoxemia and the survival rate of patients with severe coronavirus disease 2019 (COVID-19). Methods: In a randomized clinical trial, we divided sixty patients with severe COVID-19 into two groups. The intervention group received the standard treatment of severe COVID-19 with RBC exchange three to four times in 2 days. The control group only received the standard treatment. Our primary outcomes were improving hypoxemia in 7 days, recovery or discharge, and death in 28 days. We conducted Chi-square test, independent samples t-test, and Fisher's exact test to analyze the results. The ethical committee of Aja University of Medical Sciences approved the study (IR.AJAUMS.REC.1399.054), and the Iranian clinical trial registration organization registered it (IRCT20160316027081N2). Results: Twenty-nine men and thirty-one women with a mean age of 67.5 years entered the study. The frequency of hypertension and diabetes mellitus was 86.7 and 68.3%, respectively. The most common symptoms of severe COVID-19 were dyspnea (91.6%), cough (75%), and fever (66.6%). Our results showed that hypoxemia improved in 21 of the 30 patients (70%) in the intervention group and 10 of the 30 patients (33.3%) in the control group (P < 0.004). The recovery and discharge rates were 19 of 30 patients (63.3%) in the intervention group and 2 of 30 patients (6.7%) in the control group (P < 0.001). Conclusion: The RBC exchange improved the oxygenation and survival rate in patients with severe COVID-19.
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Introduction: Although neurologic involvement and neuroimaging abnormalities have been frequently identified in COVID-19 patients, the underlying factors remain unclear. In this study, we assessed the association of the neurological manifestations and neuroimaging features of hospitalized COVID-19 patients with their clinical, laboratory, and imaging characteristics. Methods: This multicenter cross-sectional study was conducted between September 2020 and March 2021 at two large academic hospitals in Tehran, Iran. We used census sampling from medical records to enroll hospitalized patients with a positive COVID-19 Polymerase chain reaction (PCR) test who underwent brain imaging due to presenting any acute neurologic symptom during hospital stay. Results: Of the 4372 hospitalized patients with COVID-19, only 211 met the inclusion criteria (35.5% with severe infection). Central nervous system and psychiatric manifestations were significantly more common in severe cases (p ≤ 0.044). Approximately, 30% had a new abnormality on their neuroimaging, with ischemic (38/63) and hemorrhagic (16/63) insults being the most common. The most frequent reasons that provoked cranial imaging were headache (27%), altered consciousness (25.6%), focal neurologic signs (19.9%), and delirium (18%). Analysis revealed a positive correlation for age, neutrophilia, lymphopenia, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) with the emergence of neuroimaging abnormalities (p ≤ 0.018). In addition, patients with new neuroimaging abnormalities had a significantly higher lung CT score than those without any pathologic findings (11.1 ± 4.8 vs. 5.9 ± 4.8, p < 0.001). Conclusion: Approximately 30% of the study population had various acute neuroimaging findings. The lung CT score, neutrophil count, and age were strong predictors of acute neuroimaging abnormalities in hospitalized COVID-19 patients.
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Introduction: As no specific pharmacological intervention has been known for COVID-19, medicinal plants may be a suitable candidate for management of this disease. The aim of this study was to investigate the efficacy of a herbal syrup from licorice as an adjuvant treatment in hospitalized patients with COVID-19. Materials and methods: 213 hospitalized patients diagnosed with COVID-19 were assigned to receive either standardized licorice syrup as an adjuvant treatment plus standard care [Syrup Group (SYRUP), N = 91], or standard care alone [Standard Group (STANDARD), N = 104], for 7 days. The primary endpoint was duration of hospitalization in survivors. The secondary endpoints included 25% increase in oxygen saturation, C-reactive protein (CRP) difference and lymphocyte difference from baseline, number of death and number of patients transferred to ICU. Results: Mean duration of admission was 5.24 days in SYRUP and 7.14 days in STANDARD (p < 0.001). Oxygen saturation increased in 86 of 91 patients (94.5%) in the licorice group, compared to 83 of 104 patients (79.8%) in the control group (p = 0.002). There was no significant difference between the two groups in the number of patients died during hospitalization (p = 0.837). Five patients in SYRUP and 16 patients in STANDARD were transferred to ICU (p < 0.026). Mean reduction in CRP (p < 0.001) and mean increase in the number of lymphocytes (p = 0.008) in SYRUP were significantly higher than STANDARD. Discussion: Licorice syrup as an adjuvant treatment demonstrated promising results on duration of hospital admission, O2 saturation as well as inflammatory markers in COVID-19 patients; however, further clinical studies with larger sample size are suggested to achieve more conclusive results.
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Purpose: This study was completed to assess the immunogenicity and safety of the FAKHRAVAC and BBIBP-CorV vaccines as a booster dose in the population with a history of receiving two doses of BBIBP-CorV vaccine. Methods: In this double-blind, parallel clinical trial, we randomly assigned healthy adults with a history of receiving two doses of the BBIBP-CorV vaccine, who then received either the FAKHRAVAC or BBIBP-CorV vaccine as a booster dose. The trial is registered in the Iranian Registry of Clinical Trial document depository (Code: IRCT20210206050259N4). Results: The outcomes that were monitored in this study were serum neutralizing antibody (Nab) activity, immunoglobulin G (IgG) level, local and systemic adverse reactions, serious adverse events, suspected unexpected serious adverse reactions, and medically attended adverse events. After administering vaccines to 435 participants, the most frequent local and systemic adverse reactions were tenderness and nausea in 23.7% and 1.4% of cases, respectively. All adverse events were mild, occurred at a similar incidence in the two groups, and were resolved within a few days. Conclusions: On the 14th day after the booster dose injection, the seroconversion rate (i.e., four-fold increase) of Nabs for seronegative participants were 87% and 84.6% in the FAKHRAVAC® and BBIBP-CorV groups, respectively. This study shows that the FAKHRAVAC® vaccine, as a booster dose, has a similar function to the BBIBP-CorV vaccine in terms of increasing the titer of virus-neutralizing antibodies, the amount of specific antibodies, and safety.
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OBJECTIVE: Nurses are considered key members to respond to incidents and disasters. As many patients are hospitalized during the coronavirus disease (COVID-19) pandemic, and nurses are directly in contact with these patients; their preparedness enables them to respond to this situation more effectively and protects their health. Therefore, the present study aimed to design and validate a questionnaire to measure the nurses' preparedness in response to COVID-19 in Iran in 2020. METHODS: This study was a mixed research aiming to develop and validate a psychometric research instrument in 2020. Based on the review of the literature regarding COVID-19 and other viral respiratory infections, the items were extracted, rewritten, and validated. In the quantitative phase, the validity of the questionnaire was evaluated in terms of face, content, and construct validity, and its reliability was evaluated based on internal consistency and stability (Cronbach's alpha and Intra-class Correlation Coefficient [ICC]). To fill out the questionnaire, the nurses were selected by random sampling. Data analysis was done by the SPSS software, version 23 (IBM Corp, Armonk, NY). RESULTS: The designed questionnaire included 9 dimensions and 50 items. The dimensions included (1) Incident Command System (ICS); (2) risk assessment and management; (3) information and communication management; (4) psychological approaches; (5) personal protective equipment; (6) prevention of contamination, isolation, and quarantine; (7) education and training; (8) patient management; and (9) features of the new coronavirus. The content and face validity of the questionnaire were approved by the specialists and experts of nursing and health in disasters and emergencies. The content validity ratio was > 0.7 for all items. The content validity index was also approved for all items. The Cronbach's alpha coefficient and ICC were respectively 0.71 and 0.72 for the total questionnaire. The total score was determined based on 5 ranges, including 50-89 (very low preparedness), 90-129 (low preparedness), 130-170 (medium-level preparedness), 171-210 (high preparedness), and 211-250 (very high preparedness). CONCLUSION: Nurses' preparedness to respond to this pandemic requires multilateral measures. Measuring the nurses' preparedness can clarify the challenges in hospital measures taken to respond to this crisis. Evaluating the nurses, determining the challenges and priorities, and finding solutions to resolve them can improve the nurses' performance in providing health care services. Preparation of nurses during pandemics can reduce the damages to this group and maximize their efforts to protect the patients. Thus, health planners and policy-makers should try to promote the nurses' awareness and preparedness.
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BACKGROUND: The newly emerged coronavirus disease 2019 (COVID-19) seems to involve different organs, including the cardiovascular system. We systematically reviewed COVID-19 cardiac complications and calculated their pooled incidences. Secondarily, we compared the cardiac troponin I (cTnI) level between the surviving and expired patients. METHODS: A systematic search was conducted for manuscripts published from December 1, 2019 to April 16, 2020. Cardiovascular complications, along with the levels of cTnI, creatine kinase (CK), and creatine kinase MB (CK-MB) in hospitalized PCR-confirmed COVID-19 patients were extracted. The pooled incidences of the extracted data were calculated, and the unadjusted cTnI level was compared between the surviving and expired patients. RESULTS: Out of 1094 obtained records, 22 studies on a total of 4,157 patients were included. The pooled incidence rate of arrhythmia was 10.11%. Furthermore, myocardial injury had a pooled incidence of 17.85%, and finally, the pooled incidence for heart failure was 22.34%. The pooled incidence rates of cTnI, CK-MB, and CK elevations were also reported at 15.16%, 10.92%, and 12.99%, respectively. Moreover, the pooled level of unadjusted cTnI was significantly higher in expired cases compared with the surviving (mean difference = 31.818, 95% CI = 17.923-45.713, P value <0.001). CONCLUSION: COVID-19 can affect different parts of the heart; however, the myocardium is more involved.
Subject(s)
COVID-19/complications , Creatine Kinase, MB Form/blood , Heart Diseases/etiology , SARS-CoV-2 , Troponin I/blood , Biomarkers/blood , COVID-19/epidemiology , Heart Diseases/blood , Heart Diseases/diagnosis , Humans , PandemicsABSTRACT
INTRODUCTION: Incidence of brucellosis was growing up in Iran during the past years. Kermanshah province-west of Iran is one of the endemic regions of the disease. The aim of this study was to evaluate the incidence and risk factors of brucellosis in Kermanshah province during a recent five-year period. METHODS: This study was an observational cross-sectional study performed on registries of the patients with brucellosis at the center for the zoonotic disease of Kermanshah University of medical sciences during 2010-2014. The data was collected using a questionnaire containing demographic data and the risk factor of brucellosis. Collected data were analyzed by SPSS-22 software using descriptive statistic, Chi-square, and student t-test. RESULTS: The five-years mean incidence of brucellosis in our study was 46.5 in one hundred thousand, and male to female ratio was 1.37/1. The most common risk factors of brucellosis in our patients were unpasteurized dairy products' consumption (47%) and occupational contact with livestock (14.4%). 84% of the patients were rural. The most common diagnostic method was the standard agglutination test within 1/160 and 1/320 titers. CONCLUSION: Risk factors of brucellosis in our study were like other studies, but in more than onethird of the patients, no risk factor was identified. Lack of livestock vaccination history and incomplete registered data about other possible transmission routes of transmission were the limitations of the study.